Steven J. Russell M.D of Massachusetts General Hospital www.massgeneral.org, Edward R. Damiano and Firas El-Khatib of Boston University www.bu.edu have developed and tested a bionic pancreas. The system consists of a smart phone that wirelessly communicates with two pumps.
The pumps deliver either insulin or glucagon which is a hormone to increase blood glucose levels via tubing that goes under the skin. The hormones are administered based on readings provided to the smart phone every five minutes from a continuous glucose monitor. In previous short-term studies, the scientists showed that the device could maintain blood glucose levels close to normal in both adults and children in carefully controlled environments.
In their new study, the team set out to assess the safety and effectiveness of the system in a home setting. The research was supported by NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) www.niddk.nih.gov and the National Center for Advancing Translational sciences (NCATS)https://ncats.nih.gov.
Results were published online on December 20, 2016 in the Lancet www.thelancet.com titled “Home Use of a BiHormal Bionic Pancreas versus Insulin Pump Therapy in Adults with Type 1 Diabetes.”
The scientists enrolled 39 adults with type 1 diabetes. Participants were randomly assigned to receive the bionic pancreas or receive usual care which consisted of conventional or sensor-augmented insulin pump therapy.
They completed one treatment for eleven days and then the other treatment for the same period. Participants were remotely monitored and engaged in normal activities during both treatments including athletics and driving.
The researchers found that participants had better blood glucose regulation with the bionic pancreas with lower average blood glucose levels of 141mg/dL vs. 162 mg/dL. There were no serious or unexpected side effects in the bionic pancreas phase of the study although more participants experienced nausea.
Patents for the system have been licensed to Beta Bionics www.beta.bionics.org. NIH is planning to do larger and longer studies to further assess the benefits and risks of the automated bionic pancreas.